3-ap in treating patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of 3-ap in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.

objectives: * determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-ap. * determine the toxic effects of this drug in these patients. outline: this is a multicenter study. patients receive 3-ap iv over 2 hours on days 1-4. treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. patients are followed every 2-3 months for up to 1 year. projected accrual: approximately 13-27 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods: * measurable disease * psa level of at least 5 ng/ml with a positive bone scan * objective evidence of progressive metastatic disease in the past 3 months defined by any of the following: * an increase in psa value of at least 25% (minimum absolute increase of 5 ng/ml) on at least 2 successive occasions, at least 2 weeks apart * a new symptomatic lesion on bone scan * a new metastases not in bone * growth of existing non-bone measurable metastatic disease note: an increase in pain or symptoms alone without other evidence of progression, or elevation of psa or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient * prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure * patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/ml and must continue leuteinizing hormone-releasing hormone therapy while on study * no known active cns metastases (excluding prior cns metastases with currently stable disease after treatment ) patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * more than 3 months hematopoietic * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl (transfusion allowed) hepatic * bilirubin no greater than 2.0 mg/dl * alt/ast no greater than 5 times upper limit of normal * albumin greater than 2.5 g/dl * chronic hepatitis allowed renal * creatinine no greater than 2.0 mg/dl cardiovascular * no myocardial infarction within the past 3 months * no unstable angina * no uncontrolled arrhythmias * no uncontrolled congestive heart failure pulmonary * no dyspnea at rest other * nutrition adequate (caloric intake considered adequate for maintenance of weight) * fertile patients must use effective contraception * no prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage i malignancy curatively resected more than 5 years ago * no active uncontrolled infectious process * no other life-threatening illness * no peripheral neuropathy greater than grade 2 prior concurrent therapy: biologic therapy * at least 2 weeks since prior biologic therapy chemotherapy * at least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * no more than 1 prior chemotherapy regimen for metastatic disease endocrine therapy * see disease characteristics * at least 4 weeks since other prior hormonal therapy including any of the following: * megestrol * finasteride * herbal products known to decrease psa levels (e.g., saw palmetto and pc-spes) * systemic corticosteroids * at least 4 weeks since prior flutamide therapy (6 weeks for bicalutamide or nilutamide) with continued evidence of progressive disease documented by at least 1 psa value after discontinuation radiotherapy * at least 8 weeks since prior radiopharmaceuticals (strontium chloride sr 89, samarium sm 153 lexidronam pentasodium) * at least 4 weeks since prior radiotherapy and recovered surgery * see disease characteristics * at least 3 weeks since prior major surgery and recovered other * no other concurrent investigational agents * no other concurrent anticancer treatment

Keywords: recurrent prostate cancer stage iv prostate cancer